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Fukuzyu FDA-483 Out

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FDA posts the form FDA-483 issued following a 2024 inspection at Japans Fukuzyu Pharmaceutical Co.

FDA Hits Novo Nordisk Over Ozempic Ad

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FDA cites a Novo Nordisk direct-to-consumer advertisement for its blockbuster diabetes drug Ozempic (semaglutide), calling the ad ...

Regenxbios Complete Response Letter Released

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FDA posts a complete-response letter that outlined last month's rejection of Regenxbios BLA for its gene therapy clemidsogene lanp...

FDA Working on Peptide Accessibility: Politico

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Politico reports that HHS secretary Robert F. Kennedy Jr. said FDA will soon approve a way to make some peptides more accessible t...

FDA Wants Randomized Trial for Huntingtons Gene Therapy

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FDA recommends that uniQure conduct a randomized, double-blind, sham surgery-controlled trial before seeking BLA approval for its ...

Merck Reports Promising Keytruda-Welireg Combo Data

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Merck says that adding Welireg (belzutifan) to Keytruda as adjuvant therapy significantly reduced the risk of disease recurrence o...

Takeda/Protagonist NDA Gets Priority Review for Polycythemia Vera

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FDA accepts for priority review a Takeda and Protagonist Therapeutics NDA for rusfertide, positioning the drug as a potential firs...

Pfizer CEO Concerned About FDA Vaccines Chief

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Pfizer CEO Albert Bourla tells TD Cowen healthcare conference that the leadership of FDAs biologics center is worrisome because it...

Intellia Gets Hold Lifted on MAGNITUDE Phase 3 Trial in ATTR-CM

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FDA removes a clinical hold against Intellia Therapeutics and its MAGNITUDE Phase 3 trial of nexiguran ziclumeran (nex-z), an expe...

Ex-FDA Leaders Accuse Trump Admin of Distorting Contraceptive Science

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Three former senior FDA officials tell a federal appeals court that the Trump administration mischaracterized the science on contr...